The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, announced today that the U.S. BOSTON, Nov.

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JANUARY 15, 2021

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. 2],[3] This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. develop this rare disease each year.[6]

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JULY 12, 2021

Finerenone 10 mg or 20 mg is indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

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NOVEMBER 29, 2021

The American Cancer Society estimates there will be more than 21,000 new cases of ovarian cancer and more than 13,000 deaths from this disease in 2021, making it the deadliest of all female reproductive system cancers. The FDA previously granted Cytalux orphan-drug , priority and fast track designations. Related Information.

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DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. during the first quarter of 2021. BUFFALO, N.Y.,

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JANUARY 11, 2021

12, 2021 /PRNewswire/ — MicroVention, Inc., based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. .

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MAY 5, 2021

Farxiga use expanded for reducing risks in patients with chronic kidney disease. Approval of the sodium-glucose cotransporter 2 (SGLT2) inhibitor was based on efficacy findings in the interventional, multicenter, randomized Dapa-CKD study. controlled trial had not received previous systemic therapy for metastatic disease.

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DECEMBER 17, 2020

Food and Drug Administration (FDA) has approved belimumab (Benlysta®), the first-ever treatment for adults with lupus nephritis (LN) who are currently receiving standard therapy. LN, or inflammation of the kidneys, is a common system of systemic lupus erythematosus (SLE), one of the most prevalent autoimmune diseases.

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JANUARY 19, 2021

19, 2021 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. NASDAQ: REGN) today announced that it will report its fourth quarter and full year 2020 financial and operating results on Friday, February 5, 2021 , before the U.S. TARRYTOWN, N.Y. , financial markets open.

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JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We Second Quarter 2021 Financial Results. Total second quarter 2021 revenue of $6.2 As of June 30, 2021, Gilead had $7.4

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SEPTEMBER 6, 2020

Basel, 7 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

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JANUARY 22, 2021

22, 2021 — The first monthly shots to treat adults with HIV were approved by the U.S. © 2021 HealthDay. Posted: January 2021. FRIDAY, Jan. Food and Drug Administration on Thursday. “Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition.

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APRIL 7, 2021

today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. . Key AbbVie abstracts and presentation details for the 2021 AAN Annual Meeting program are outlined below. Advanced Parkinson’s Disease.

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AUGUST 1, 2021

to $6.14; Raises 2021 Adjusted Diluted EPS Guidance Range from $12.37 Based upon the momentum of our business, we are raising our full year 2021 EPS guidance and believe AbbVie is very well positioned for the long term.” ” Second-Quarter Results. Worldwide net revenues were $13.959 billion, an increase of 33.9

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DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. BASEL, Switzerland, Dec.

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JANUARY 15, 2021

15, 2021 — An inhaled medication might make every day physical activity a bit easier for patients with serious scarring of the lungs, a new clinical trial finds. 13 in the New England Journal of Medicine , involved patients with high blood pressure in the lungs caused by interstitial lung disease (ILD). FRIDAY, Jan.

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JUNE 7, 2022

New Indication for Amgen’s Fifth FDA-approved Biosimilar. Now Approved to Treat All Available Rituxan ® Indications. Overall, 311 patients were randomized and treated with RIABNI, rituximab RP approved in the EU (rituximab-EU) or rituximab RP approved in the US (rituximab-US).

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MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk profile and indication for use in eligible adults remain consistent with the EUA. More than 11.6

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MARCH 11, 2021

Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. Session Date and Time: Sunday, April 11, 2021 2:00 PM – 3:45 PM ET.

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AUGUST 3, 2021

today announced financial results for the second quarter of 2021. 2021 total revenues guidance reaffirmed at $25.8-$26.6 COVID-19 update : Compared to the first quarter of 2021, we have seen gradual recovery from the impacts of the COVID-19 pandemic. As a result, we expect a 50-60% year-over-year Parsabiv sales decline in 2021.

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NOVEMBER 18, 2020

By the second quarter of 2021, the company plans to amend or file a new emergency use request so people who think they’re infected with COVID-19 can communicate with a medical professional online through a dedicated website to arrange a prescription and overnight delivery of the test kit. Meanwhile, Moderna Inc. percent effective.

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DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. ” As previously announced, the planned trial will evaluate the efficacy of Berubicin in patients with GBM who have failed primary treatment for their disease.

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JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S. Jansen, Ph.D.,

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MAY 18, 2021

Basel, 23 April 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. Endometrial cancer is the most common gynecologic cancer in the U.S.

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APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. Sanofi has become a member of the top five companies of the 2021 Access to Medicine index.

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MAY 6, 2022

Food and Drug Administration (FDA) authorized on May 10 , 2021. The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

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JULY 8, 2021

ADUHELM should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. Food and Drug Administration (FDA) has approved an updated label for ADUHELM (aducanumab-avwa) injection 100 mg/mL solution. ADUHELM is indicated for the treatment of Alzheimer’s disease.

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DECEMBER 18, 2020

18 December 2020 — The US Food and Drug Administration (FDA) has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anemia of chronic kidney disease (CKD).

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NOVEMBER 26, 2020

(NYSE American: PLX) (TASE: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A.,

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SEPTEMBER 28, 2021

Roche today announced data from across its growing neuromuscular portfolio at the planet Muscle Society (WMS) Virtual Congress 20 – 24 September 2021. Our goal is to still lead the way in developing transformative medicines for neuromuscular diseases. At WMS 2021, data from the continued open label RAINBOWFISH study were presented.

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JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. . HELLERUP, Denmark , Jan.

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JANUARY 7, 2021

8, 2021 11:05 UTC. NASDAQ: AUPH / TSX: AUP) (the “Company”) today announced that members of the management team will participate in two upcoming virtual investor conferences and participate in a panel discussion hosted by Dr. Scott Gottlieb, former FDA Commissioner: H.C. Wainwright Virtual BioConnect 2021 Conference.

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SEPTEMBER 8, 2021

today announced that data reinforcing the potential of immunotherapies to impact clinical outcomes for patients will be featured at the European Society for Medical Oncology (ESMO) 2021 Virtual Congress from September 16-21. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries.

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SEPTEMBER 8, 2021

Adds Rezurock™ (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. Sanofi has entered into a definitive merger agreement with Kadmon Holdings, Inc.

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JUNE 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, Eli Lilly and Company’s (NYSE: LLY) investigational antibody therapy for Alzheimer’s disease (AD). Dementia due to Alzheimer’s disease is the most common form of dementia, accounting for 60 to 80 percent of all cases 1.

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MAY 31, 2022

Without treatment, infants do not achieve these milestones in the natural history of the disease. “The priority review and subsequent approval of Evrysdi for babies under two months of age speaks to the urgent ongoing need for additional treatment options for babies with SMA,” said Levi Garraway, M.D.,

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DECEMBER 15, 2020

A healthy immune system defends the body against disease and other conditions. Autoimmune disease impacts different parts of the body, weakening functionality. Researchers are aware of more than 80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. It may be life-threatening.

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